Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01462695 · ADVERSE EVENTS

Adverse events

Sunitinib Malate in Treating Younger Patients With Recurrent, Refractory, or Progressive Malignant Glioma or Ependymoma · Source last updated 2015-08-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Not reported
Other-event reporting threshold
0%

One stratum A patient did not receive any study drug and was excluded from the summary of adverse events. SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs) or grade 5 adverse events resulting in death. The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Stratum A: Recurrent High Grade Glioma

Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. sunitinib malate: Given PO diagnostic laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies

14 / 168 / 16Not reported / Not reported
Stratum B: Recurrent Ependymoma

Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.

9 / 136 / 13Not reported / Not reported

Group identifiers: EG000: Stratum A: Recurrent High Grade Glioma · EG001: Stratum B: Recurrent Ependymoma

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      13
    term
    Death NOS
  2. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Gait disturbance
  3. organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      13
    term
    Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
  4. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Dysarthria
  5. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Facial nerve disorder
  6. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Headache
  7. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Hydrocephalus
  8. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Intracranial hemorrhage
  9. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Paresthesia
  10. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Peripheral motor neuropathy
  11. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Seizure
  12. organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Rash maculo-papular

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Diarrhea
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Nausea
  3. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Vomiting
  4. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Fatigue
  5. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Alanine aminotransferase increased
  6. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Aspartate aminotransferase increased
  7. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Lipase increased
  8. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Lymphocyte count decreased
  9. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      13
    term
    Neutrophil count decreased
  10. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Serum amylase increased
  11. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    White blood cell decreased
  12. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Muscle weakness left-sided
Complete source fields
description
One stratum A patient did not receive any study drug and was excluded from the summary of adverse events. SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs) or grade 5 adverse events resulting in death. The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
event Groups
  1. description
    Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. sunitinib malate: Given PO diagnostic laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
    id
    EG000
    other Num Affected
    8
    other Num At Risk
    16
    serious Num Affected
    14
    serious Num At Risk
    16
    title
    Stratum A: Recurrent High Grade Glioma
  2. description
    Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
    id
    EG001
    other Num Affected
    6
    other Num At Risk
    13
    serious Num Affected
    9
    serious Num At Risk
    13
    title
    Stratum B: Recurrent Ependymoma
frequency Threshold
0
other Events
  1. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Diarrhea
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Nausea
  3. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Vomiting
  4. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Fatigue
  5. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Alanine aminotransferase increased
  6. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Aspartate aminotransferase increased
  7. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Lipase increased
  8. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Lymphocyte count decreased
  9. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      13
    term
    Neutrophil count decreased
  10. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Serum amylase increased
  11. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    White blood cell decreased
  12. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Muscle weakness left-sided
serious Events
  1. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      13
    term
    Death NOS
  2. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Gait disturbance
  3. organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      13
    term
    Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
  4. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Dysarthria
  5. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Facial nerve disorder
  6. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Headache
  7. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Hydrocephalus
  8. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Intracranial hemorrhage
  9. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Paresthesia
  10. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    term
    Peripheral motor neuropathy
  11. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Seizure
  12. organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    term
    Rash maculo-papular

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice